Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/1406—Septums, pierceable membranes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/16—Holders for containers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2006—Piercing means
  • A61J1/201—Piercing means having one piercing end
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2048—Connecting means
  • A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2048—Connecting means
  • A61J1/2055—Connecting means having gripping means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2048—Connecting means
  • A61J1/2065—Connecting means having aligning and guiding means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2006—Piercing means
  • A61J1/2013—Piercing means having two piercing ends

Definitions

• the invention relates to a transfer device for removing or transferring a medium from or into a bottle with a bottle neck, which can be closed by a closure
• a transfer element such as needle puncture needle, cannula, spike or perforation, for piercing the closure.
• the dry substance is usually delivered in an injection bottle, a so-called vial. Also primarily liquid medicines are offered in vials.
• a connector transfer device
• the other container can be z.
• these connectors which are also referred to as adapters and composed of adapter parts, can have a steel cannula or a plastic mandrel surrounded by a collar forming a hollow cylindrical body which bears on the flange-like edge with the crimp cap of the vial, in particular made of aluminum snaps. From the bottom wall of the collar, the puncture needle goes out in particular in the form of the steel cannula and extends in the longitudinal direction of the hollow cylindrical body.
• Such adapters no longer meet today's requirements for vial adapters, for several reasons.
• the prior art vial adapters of the prior art generally do not provide any aerosol and leak tightness.
• the corresponding adapters basically do not provide any aerosol and leak tightness.
• a transfer device consists of a cap-like outer guide part and a tubular inner guide part which are telescopically displaceable relative to one another.
• the origins of the inner guide part snap into recesses of the outer guide part that run on the inside.
• tongue-like elements emanating from the inner guide part are bent outward, with the result that the outer guide part is displaced outwards in the region of the recesses, so that the latching between the inner and outer guide parts is released.
• Another disadvantage is that the transfer device after use can be easily removed from the vial, so again a risk of injury to the user arises.
• a transfer device which comprises a hollow in a cylindrical structure axially adjustable needle holder with transfer needle.
• the structure has a wall-shaped stop which can be placed on the opening of a storage container to be pierced and is penetrated by the transfer needle during actuation of the transfer device.
• a transfer device has an actuator in order to be able to axially adjust a mandrel having a first part to a surrounding a closure of a bottle second part by turning.
• DE 10 2005 006 771 AI discloses a fluid transfer device, the structure comprising a sleeve-shaped guide s with surrounded by this needle holder with puncture needle.
• the sleeve-shaped guide structure points to a Embodiment axially extending movable sleeve strips having clamping elements for detecting a bead-like edge of a vial.
• a transfer device according to WO 2009/029390 AI has inner and an outer adapter part, which are welded in the flange-like edge region by means of ultrasound.
• the transfer device surrounds a vial, which in turn is surrounded by an envelope with which the transfer device is locked.
• the present invention is u. a. the object of providing a transfer device, so a vial connector or adapter available to provide increased exposure security.
• One aspect aims at avoiding leakage leading to a risk after the closure has been pierced.
• the invention provides u. a. in that the first adapter part, after displacement of the second adapter part along the first adapter part in the direction of the closure and latching of the second adapter part, is fixed inseparably on the bottle or around the bottle.
• radially adjustable fixing elements emanate from the first adapter part, via which the first adapter part is fixed inextricably attached to the bottle after displacement of the second adapter part along the first adapter part in the direction of the closure and latching of the second adapter part with proper handling of the transfer device.
• the invention is characterized in that the first and second adapter part surround the bottle in such a way that a closed envelope results, so that an aerosol tightness and leakage safety is ensured.
• the first adapter part is pot-shaped and takes up the bottle body.
• the second adapter part, from which the transfer element emanates likewise has a hood-shaped or cup-shaped geometry, which can engage with the first adapter part.
• a seal can emanate from the second adapter part in order to seal the first and second adapter parts with respect to the bottle.
• a transfer device which after use, that is to say after piercing the closure, can no longer be detached from the bottle, which is mainly referred to as vial. It can be provided that before using the transfer device accidental contact with the tip of the transfer element is excluded, so that a risk of injury is avoided.
• transfer element is z. B. may be a needle, a cannula, a spike or other perforating device.
• transfer element is intended to cover any suitable element which enables a transfer of the medium. Therefore, various terms are used, in particular puncture needle or cannula, without thereby limiting the teaching of the invention.
• the invention is characterized in that the first adapter part comprises a bottle circumference surrounding a hollow cylinder geometry with flaschenver gleich put extending end edge having skirt portion - also Mantelwandung - a bottom of the bottle at least partially, preferably completely covering the bottom portion and an end edge side extending holding portion from which the fixing elements, which may be formed tongue or web-like, go out, which in the radial direction of the first adapter part are pivotable or bendable or expandable and extending in the direction of the longitudinal axis of the first adapter part.
• the fixing elements After introducing the vial into the first adapter part, the fixing elements can consequently be supported at the transition between bottle neck and bottle body, with the result that the first adapter part can no longer be detached from the vial.
• the holding portion is a running in the end edge region of the skirt portion ring portion, the z. B. fixed to the edge of the jacket wall as is clamped or glued, which extends at least partially along the inside of the shell portion and extending over the end edge extending in the axial direction deformable first projections.
• the latter opens up the possibility that the first and second adapter parts can be locked to one another.
• second projections which can be locked or locked in guides such as slotted slots of the second adapter part with locked adapter parts. From the guides then the second protrusions are not removable with conventional handling of the transfer device.
• the second adapter part has an outer hollow-cylindrical section and a boundary wall extending transversely to its longitudinal axis, from which the puncturing needle-that is, the transfer element-emerges or which is penetrated by the puncture needle.
• Each guide for each projection has an outgoing from the free end edge of the outer cylinder portion and extending in the longitudinal direction of the first portion, which merges into a transverse to the first portion limiting wall side extending second portion in which guided in this second projection is fixable as lockable which protrudes radially from the outside of the jacket wall of the holding portion of the first adapter part.
• the second portion of the guide in the axial direction has a cross-sectional reduction, the axial extent is smaller than the axial extent between the maximum distance between the first and second projection.
• the axial extent between the boundary wall and the opposite edge of the second section of the guide should be at least equal to the maximum distance between remote sections of the first and second projections in the axial direction.
• the second adapter part must first be guided in the axial direction, ie in the longitudinal direction of the vial in the first section of the guide, that is adjusted in the direction of the first adapter part, then by rotating the second projections in the limited by the cross-sectional reduction end portion of the second portion of the guide bring in and fix it, so that a solubility between the first and second adapter part is given.
• the inner edge forming boundary of the second portion of the guide in the direction of the boundary wall should at least partially inclined to the longitudinal axis of the first adapter part and thus the transfer device and include an obtuse angle to the longitudinal axis.
• a proposal of the invention provides that the inner cross section of the hollow cylindrical portion of the second adapter part corresponds to the outer cross section of the jacket portion of the first adapter part.
• a safe guide is also due to the overlap of the adapter parts or by the previously discussed axial running guides such as slot slots or z.
• an inner hollow cylindrical portion extends, wherein preferably a designated as a first protective element protective element is arranged in particular displaceable, wherein in the absence of connection of the first adapter part with the second adapter part, the top of Puncture needle between the protective element and the boundary wall of the outer hollow cylindrical portion extends.
• the invention further provides that the second projection in projection of the outside of the jacket portion has a rectangular or trapezoidal geometry with a corner, which in mutually fixed first and second adapter part interacts with a stage effecting cross-sectional reduction of the second portion of the guide to prevent disengagement.
• a further embodiment of a transfer device which is no longer detachable from the vial after piercing the closure, provides that the first adapter part of the transfer device has a first outer hollow-cylindrical section extending from the side of the bottle and a first outgoing from the latter Has inner hollow cylindrical portion of smaller cross-section, that the first outer hollow cylindrical portion axially forming the fixing tongue-shaped portions having radially in each free end portion radially inwardly projecting projections for gripping a portion of the bottle, in particular its bead-like edges, and the second adapter part a second outer hollow cylindrical Section, which is displaceable along the outer side of the first outer hollow cylindrical portion of the first adapter part, that is suppressed in radially outwardly directed radial displacement of the tongue-shaped portions when surrounded by the second outer hollow cylindrical portion first outer hollow cylindrical portion of the first adapter part, and that a third outer hollow cylindrical portion of the second outer hollow cylindrical portion of the second adapter part small eren cross-section, within
• a transfer device which consists of the first, a bottle or its neck fixable first adapter part and a two-part second adapter part, which are axially displaceable relative to each other and to the first adapter part.
• the outer part of the second adapter part that when the hollow cylindrical portion of larger cross-section covers the first outer hollow cylindrical portion of the first adapter part over a fixed axial length, that the particular tongue-like edge of the bottle behind tongue-shaped portions are no longer adjustable to the outside with the result that a release of the bottle is excluded.
• lock the adapter parts to prevent retraction of the second adapter part.
• the outer part of the second adapter part is locked to the first adapter part.
• a protrusion projecting radially inward from the second outer hollow-cylindrical portion of the second adapter part acts with a recess or step or an identical geometric change of the first hollow cylindrical section of the first Adapter parts together such that an axial displacement of the second adapter part is prevented to the first adapter part against the penetration direction.
• the first and second adapter part forms a - viewed in the axial direction - rigid unit. If the first fuse is removed after the transfer device has been pushed onto a vial, the second adapter part can be displaced as a subunit in the penetration direction, whereby the desired latching between the first and second adapter part takes place with the result that the tongue-shaped, the radially after inside projecting protrusions fixing elements are no longer adjustable to the outside, so that a release of the bottle is excluded.
• the penetration needle is not adjustable to the outer part of the second adapter part. If the transfer device is fixed by adjusting the second adapter part, ie after removal of the first fuse on the bottle, the second fuse is removed, so that the second inner portion to the second and third outer hollow cylindrical portion having the outer part of the second adapter part axially in the direction the bottle is displaceable, so that the outgoing from the inner part of the second adapter part cannula can pierce the closure.
• a development proceeds from the first inner portion of the first adapter part to a protective element designated as a second protective element, between the second inner portion of the second adapter part when it is unused Transfer device runs the tip of the penetration needle.
• the adapter parts or their sections should be geometrically designed such that during the axial displacement of the second adapter part to the first adapter part, the third outer section is guided on the outside and the second inner section of the second adapter part on the inside along the first inner section of the first adapter part.
• the first securing device should have a geometry of a ring section, which passes through a slot running in the third outer section of the second adapter part and engages in a recess oriented thereon, such as a groove in the outer wall of the first inner section of the first adapter part.
• the second inner portion of the second adapter part yakionsnadelspitzen nurse one of the puncture needle penetrated bottom wall and tikionsnadelspitzenabgewandt one of the peripheral wall, in particular from the outer end portion of the second inner portion of the second adapter part radially outwardly directed, preferably circumferential flange portion having its effective radial Extension is at least equal, preferably greater than outer cross-section of the third outer portion of the second adapter part.
• This flange portion serves as a handle to axially adjust the second adapter part to the first adapter part and the inner portion of the second adapter part to the outer portion.
• the second fuse may also have a geometry of a second annular portion which is fixed at axial Un displaceability between the first and second adapter part between the free end edge of the third outer portion and the flange portion of the second inner portion of the second adapter part.
• the first and / or second protective element by means of which the puncture needle tip in unused transfer device against unintentional contact is protected, a disc element, wherein the first, preferably both the first and the second protective element, are arranged axially displaceable in the first and second adapter part.
• a development of the invention provides that in at the second outer hollow cylindrical portion of the second adapter part in the use position of the transfer device latched first outer hollow cylindrical portion of the first adapter part between the second and third outer hollow cylindrical portion of the second adapter part extending intermediate wall between the first outer hollow cylindrical portion and the first inner hollow cylindrical portion of the first adapter part extending intermediate wall rests.
• the second securing element remains between the third outer section and the second inner section of the second adapter part.
• the invention itself inventively characterized by the fact that when adjusting the second part in the penetration direction of the puncture needle, the second adapter part with the first adapter part acts such change that an adjustment of the second adapter part is prevented against the first adapter part against the penetration direction.
• first and second adapter part are designed such that they form a closed container when surrounding the bottle, is excluded by the escape of aerosol or after piercing the closure leakage from the existing medium in the bottle to the outside, so that contamination z. B. by inhalation, on the skin, if necessary. Orally, can not be done.
• the second element having the transfer element can have a seal by which the second adapter part is sealed against the bottle, in particular both with respect to the bottle and the first adapter part.
• the invention is also distinguished by a transfer device for removing or transferring a medium from or into a bottle with a bottle neck, which can be closed by a closure, comprising a first adapter part positionable on the bottle and an interacting with the first adapter part Slidable second adapter part longitudinal direction of the bottle with a transfer element for the passage of the closure, wherein when the first and second adapter parts are pushed together, they form a closed container surrounded by the bottle.
• the second adapter part has a seal through which a seal of the second adapter part relative to the bottle and / or the first adapter part takes place.
• An insolubility of the adapter parts is preferably also given.
• the insolubility of the adapter parts on the engagement of projections in recesses is achieved, which are only in the penetration direction of the transfer element such as cannula to move against each other and can not be separated in the opposite direction.
• the locking can be done by tongue-like elements having latching hooks, which in turn interact with corresponding elements.
• the tongue-like elements may have different lengths.
• the invention also includes sealing elements which allow the escape of liquids, dusts, aerosols or the like. from a closed room.
• these sealing elements can seal the adapter parts to each other or each other.
• sealing elements are possible, the recesses, recesses, projections, which may also be circumferential and annular, or the like, to complete the space against the environment.
• the sealing elements may lie between the outer parts of the adapters, between the inner or inner and outer parts of the adapters. If necessary, the sealing elements can also seal directly opposite the bottle.
• sealing elements can be designed such that even guide grooves form, so that the adapter parts can be moved into each other or bottles in the adapter parts easier.
• the invention also makes it possible to avoid leakage leading to a risk of leakage after the closure has been pierced.
• the invention also provides a kit comprising a container with a medical device, a bag with solvent for dissolving the medical device and a transfer device for mixing the solvent with the medical device.
• Fig. 1 is an exploded view of a first embodiment
• FIG. 2 shows a first adapter part of the transfer device according to FIG. 1, FIG.
• FIG. 3 shows a second adapter part of the transfer device according to FIG. 1, FIG.
• Section along the line HH an alternative to the embodiment of the transfer device according to FIGS. 1 to 7b), shown in plan view, a side view of the transfer device according to FIG. 18, a section along the line AA in FIG. 18, a variant of the transfer device according to FIG. 18 in section as well as a detail,
• FIG. 20 an exploded view of the transfer device according to FIGS. 18 to 21, the transfer device according to FIG. 22 in plan view and in section along the line BB, the transfer device according to FIG. 22 in plan view and in section along the line CC 22 in plan view and in section along the line DD, the transfer device according to FIG. 22 in plan view and in section along the line EE, the transfer device according to FIG. 22 in plan view and in section along the line FF, FIG 22 in plan view and in section along the line GG, FIG. another embodiment of a transfer device as an alternative to that of FIGS. 18 to 28b), shown in plan view, a side view of the transfer device according to FIG. 29, a section along the line AA in FIG. 29, a detail of FIG.
• the transfer device 29 to 32 in plan view and in section along the line CC the transfer device according to FIGS. 29 to 32 in plan view and in section along the line DD, the transfer device according to FIGS. 29 to 32 in plan view and in section along line EE, the transfer device according to FIGS. 29 to 32 in plan view and in section along the line FF, the transfer device according to FIGS. 29 to 32 in plan view and in section along the line GG, the transfer device according to FIGS 32 in plan view and in section along the line HH and the transfer device of FIGS. 29 to 32 in an exploded view.
• transfer devices are shown, by means of which of a bottle or a vial, so-called vial, fluids such as dry substances or liquids such as water or solvents, which are mixed for infusion or injection purposes prior to their application or administration, are transferred. Use for instillation or solvent bags is also possible.
• the applications are purely exemplary.
• Corresponding transfer devices are also referred to as connectors or adapters.
• a corresponding transfer device is required in order to perforate the closure of the vial by means of a transfer element such as a puncture needle - such as steel cannula - and then via the transfer device, the fluid to be removed from the vial z.
• a transfer element such as a puncture needle - such as steel cannula - and then via the transfer device, the fluid to be removed from the vial z.
• the figures to be removed transfer devices have telescopically arranged and mutually adjustable parts, which are also referred to as the first and second adapter part.
• the transfer device will hereinafter be referred to as a connector and the vial to be connected to it as a vial.
• the first adapter part is also called Vialhalter and the second adapter part as a cannula holder.
• the connecting element which produces the connection to the interior of the vial will be referred to as a cannula, without this being restricted to function and design.
• the connector 10 has a first adapter part 12 and a second adapter part 14 as essential elements.
• the first adapter part 12 has a pot Geometry with a designated as a peripheral wall peripheral wall 16 and a bottom wall 18 to receive a vial, so vial 20, which is inserted into the first adapter part 12.
• the bottom wall 18 it is ensured that the vial 20 remains in the first adapter part 12.
• the bottom wall 18 does not have to be completely closed for this purpose.
• a closed bottom wall 18 is provided to provide a closed system that provides the potential for aerosol and leak tightness, as described below.
• a ring element or ring portion 22 designated retaining element is provided, the end edge side in the axial direction compressible, elastic first projections, of which some are identified by the reference numerals 24, 26.
• the ring element 22 engages in sections the end edge of the peripheral wall 16 in order to ensure a fixation.
• the tongue-shaped elements 28, 30 are inclined to the longitudinal axis 32 of the first adapter part 12 and thus of the vial 20, whereby a backup of the first adapter part 12 takes place on the vial 20 ; 4 and 7 mediate, the tongue-shaped elements 28, 30 are based on positioned in the first adapter part 12 vial 20 on between the bottleneck 34 of the vial 20 and the cylindrical body 36 obliquely also as transition to be designated connecting wall 38 from , Thus, the vial 20 from the first adapter part 12 can not be pulled out.
• the first adapter part 12 is thus the vial holder.
• the bottleneck 34 has a peripheral bead 40 in the region of its opening.
• the opening of the vial 20 is closed by a plug 42. It should also be noted that typically after sealing the vial 20 with the plug 42, an aluminum crimp cap is applied. On this can be a flip-off cap made of plastic. This flip-off cap is withdrawn from the aluminum crimp cap so that an opening is formed in the center of the aluminum crimp cap so that the stopper 42 is visible.
• the second adapter part 14 which can also be referred to as an adapter shell or outer part, comprises a hollow-cylindrical section 44 which is delimited from the wall 46 which extends transversely to the longitudinal axis 32 and also has a cylindrical extension 48, from which, on the one hand, a cannula is designated Penetration needle 50 goes out and on the other hand outside a Abbrechkonnektor 52 is placed.
• the second adapter part 14 is thus the cannula holder.
• guide-forming recesses 56, 58 are formed (Fig. 3), each composed of an axially extending portion 60 and a transverse to this and along the wall 46 portion 62.
• Each guide 56, 58 is associated with a second projection 64, 66 projecting radially outward from the circumferential wall 16 of the first adapter part 12 (FIG. 2) in order to be able to lock the first adapter part 12 to the second adapter part 14 in the manner described below.
• an inner hollow cylindrical portion 68 Coaxially to the outer hollow cylindrical portion 44 extends an inner hollow cylindrical portion 68 within which the cannula 50 extends, but does not protrude beyond its end edge 70, as is apparent in particular from FIGS. 4 to 7.
• a disk-shaped protective element 72 is received by clamping in the embodiment according to the drawings in the axial direction the inner hollow cylindrical portion 68 is adjustable.
• the tip 74 of the cannula 50 extends between the protective member 72 and the wall 46, thus being concealed outwardly so as to protect a user from injury.
• the protective element 72 represents an embodiment which is not mandatory.
• z. B. instead of the disc-shaped protective element 72 from the end edge 70 of the inner hollow cylindrical portion 68 z. B. emanates a membrane which is destroyed during assembly of the adapter parts 12, 14 and the axial displacement of the second adapter part 14 in the direction of the vial 20 and thus the first adapter part 12.
• the transverse to the longitudinal axis 32 extending inner portion 62 of the guide 56, 58 has a formed by a step 76 reduction in the axial direction on the cross section.
• the section 62 experiences a quasi "constriction", ie, that the distance between the free edge or corner 78 of the respective second projection 64, 66 and the apex region of the first projections 24, 26 is greater than the distance between the The top of the step 76 and the opposite edge of the portion 62. Consequently, in order to overcome the step 76, the first projections 24, 26 must be squeezed in.
• the projections 24, 26 relax again, with the result that when a rotation of the first adapter part 12 to the second adapter part 14 in the direction of the step 76 takes place, projecting from the outside of the jacket wall 16 projection 64, 66 prevents further rotation by interacting with the step 76.
• the first and second adapter parts 12, 14 are inseparable from each other Also, removal of the vial 20 is not possible.
• FIG. 4 shows the position in which the second adapter part 14 is placed on the first adapter part 12.
• the second adapter part 14 with its outer hollow cylindrical portion 44 surrounds the jacket wall 16 and is guided by this.
• inner diameter of the hollow cylindrical portion 44 and outer diameter of the casing wall 16 are matched accordingly.
• the guide ensures that the cannula is slidable along the longitudinal axis 32 of the vial 20 when the first and second adapter members 12, 14 are telescoped.
• the ribs 17, 19 extending in the longitudinal axis direction serve to align the adapter parts 12, 14 with each other in the correct position in order to be displaced relative to each other. Also, the shifting is facilitated because a line-shaped contact between the adapter parts 12, 14 is generated. By the ribs 17, 19 and tilting is prevented.
• Fig. 5 the position is shown, the cannula 50 has penetrated the plug 42 and the cannula tip 74 is connected to the interior of the vial 20.
• the upper adapter part or second adapter part 14 to the lower or first adapter part 12 is rotated (Fig. 6), so that the second projections 64, 66 along the along the wall 46 extending portions 62 of the guides 56, 58 are adjusted.
• Locking of the first and second adapter parts 12, 14 occurs when the second projections 64, 66 have overcome the steps 76 in the sections 62 of the guides 56, 58 and are in the respective end section 80 of the guides 56, 58.
• steps 76 it is previously necessary that the first protrusions 24, 26 projecting axially from the end edge of the ring element 22 are compressed to the required extent.
• the lock is designed so that it can only be solved with an additional tool or with at least 300 N trigger force, for example.
• the breakaway connector 52 may be destroyed and the mixing procedure between the drug present in the vial 20 and a liquid located in a bag previously connected to the breakout connector 52.
• a Luer-Lock connection o. ⁇ . possible.
• the snap-off connector or the like such as a luer-lock connector, can also be a syringe, bottle or similar container. The same applies to all embodiments.
• FIGS. 8 to 17 show a second embodiment of a connector 100, which likewise consists of a vial holder extending on the vial side as the first adapter part 112 and a second adapter part 114 having the cannula 50 as a cannula holder.
• the connector 100 is also designed such that after its connection to the vial 20, an unintentional or uncontrolled release of the vial 20 is no longer possible, as will be explained below.
• the first or inner adapter portion 112 includes a first outer hollow cylindrical portion 116 surrounding, when properly used, the bead 40 of the vial 20, and an inner hollow cylindrical portion 118 having a smaller diameter than the outer hollow cylindrical portion 116. Between the hollow cylindrical sections 116, 118 extends a transversely, in particular perpendicular to the longitudinal axis 32 of the connector 100 and thus connected to the vial 20 state to the longitudinal axis of the vial 20 extending intermediate wall 120th
• the outer hollow-cylindrical portion 116 has separated and to the extent necessary resilient tongue-shaped portions by axially extending slots 122, two of which are exemplified by the reference numerals 124, 126.
• the tongue-shaped sections 124, 126 have end-to-end protrusions (see projection 128) that encircle the bead-like edge 40 of the neck of the neck, when the first adapter part 112 is properly connected to the vial 20, as will be seen below with reference to the figures.
• the second or outer adapter part 114 consists of two telescopically adjustable parts, namely an outer part 130 and an inner part 132, from which the puncture needle 50 starts.
• the outer part 130 includes a portion 134 called a second outer hollow cylindrical portion and a third outer hollow cylindrical portion 136 having different diameter.
• the third outer hollow cylindrical portion 136 is smaller in cross section than the second outer hollow cylindrical portion 134, whose inner diameter is adapted to the outer diameter of the first outer hollow cylindrical portion 116 of the first adapter part 112, whereby an axial guidance is made possible.
• the inner diameter of the third outer hollow cylindrical portion 136 is adapted to the outer diameter of the first inner hollow cylindrical portion 118 of the first adapter part 112, whereby also takes place an axial guidance.
• first and second adapter parts 112, 114 are secured against axial displacement relative to one another via a first securing device 138 preferably having the geometry of a ring section.
• the fuse 138 extends along a further intermediate wall 140 extending between the second and third hollow cylindrical sections 134, 136 and extending parallel to the intermediate wall 120 and penetrates a slot in the third outer hollow cylindrical section 136 and extends partially in a recess aligned with the slot or groove in the first inner hollow-cylindrical portion 118 of the first adapter part 112.
• a second fuse 146 extends between the end edge 142 of the third outer cylinder portion 136 and a flange extension extending from the inner or second portion 132 of the second adapter portion 112.
• the inner part 132 of the second adapter part 114 has a hollow cylindrical shape, the outer diameter of the inner diameter of the first inner hollow cylindrical portion 118 of the first adapter part 112 is adapted, whereby an axial guidance is made possible. Furthermore, the second part 132 of the second adapter part 114 is secured relative to the first inner hollow-cylindrical section 118 by means of interengaging sections, in particular a preferably circumferential rib 133 which projects beyond the peripheral wall of the hollow cylinder-shaped inner or second part 132 of the second adapter part 114 and in FIG a correspondingly adapted recess 153 in the inside of the first inner hollow cylindrical portion 118 of the first adapter part 112 engages.
• a disc-shaped protective element 172 can be clamped by the first inner hollow-cylindrical section 118 of the first adapter part 112 according to a non-mandatory embodiment which may have an opening in the center so as not to hinder the penetration of the cannula 50 when the stopper 42 is penetrated.
• the disc element can also be provided to be destroyed membrane.
• FIGS. 11-17 it can be seen how the connector 100 is connected to the vial 20 and the plug 42 is penetrated.
• the figures are self-explanatory.
• the connector 100 is aligned with the bottle neck 34 of the vial 20 such that the longitudinal axis of the connector 100 is aligned with the longitudinal axis 32 of the vial 20 is aligned.
• the second adapter part 114 is arranged relative to the first adapter part 112 due to the fuses 138, 146 and the interlocking protrusions such that the first adapter part 112 can overcome the bead 40 of the bottle neck 34, ie the tongue-shaped sections 124, 126 can be spread outside, then spring back as soon as the bead 40 is overcome and thus the projections 128 of the tongues 124, 126 can engage behind the bead 40.
• the positioning of the connector 100 after engaging behind the bead 40 is shown in FIG. 13.
• the first fuse 138 extending along the intermediate wall 140 and securing the first and second adapter parts 112, 114 against axial displacement is removed (FIG. 14), so that an axial displacement of the second adapter part 114 takes place with a further axial force.
• the holding force is overcome, which is generated by the or the protrusions 133 and also referred to as a rib clamping rib, which connect the inner or second part 132 of the second adapter part 114 with the first inner hollow cylindrical portion 118 of the first adapter part 112.
• Fig. 15 the position is shown in which the second outer hollow cylindrical portion 134 surrounds the first outer hollow cylindrical portion 116 of the first adapter part 112 in a circumference, that a bending of the tongue-shaped and not to be designated as elements 124, 126 to the outside not more is possible.
• the projection 147 which previously prevented withdrawal of the second adapter part 114 to the first adapter part 112, engages behind a recess in the free edge area of the tongue-shaped elements 124, 126 which is adapted by a stepped cutout 148, thereby ensuring that the second adapter part 114 is retracted, ie axial adjustment against the penetration direction, is not possible.
• the second outer hollow-cylindrical portion 134 thus acts as a clamping ring for the first outer hollow-cylindrical portion 116 of the first adapter part 112, which can also be referred to as bell, at the end, as a result of which directed radially outward adjustment of the tongue-shaped elements 124, 126 is prevented. This creates a closed space prior to puncturing the plug so that no aerosols arising through the opening of the vial escape to the outside.
• the second fuse 146 is removed so that the inner part 132 of the second adapter part 114 having the cannula 50 can be moved by axial force acting on the flange handle 144 in the penetration direction to penetrate the plug 42, as a comparison of FIG. 15 to 17 clarified.
• the disc-shaped protective element 172 is pressed by the inside running through the cannula 50 transverse wall 150 of the inner part 132 for abutment against the outside of the plug 42 and the outside covering aluminum cap.
• the protrusion or clamping rib 133 protruding radially from the outer wall of the hollow cylindrical section of the inner part 132 of the second adapter part 114 engages in a recess 152 present in the inner wall of the first inner hollow cylindrical section 118 of the first adapter part 112 or engages behind a step 152. to preclude retraction of the inner part 132 of the second adapter part 114.
• FIGS. 18 to 28 show an alternative to the embodiment of FIGS. 1 to 7, so that the same reference numerals are used in principle for identical elements.
• the representations of the corresponding transfer device 200 to be designated as a connector are self-explanatory.
• the adapter parts are unsolvable by latching an outer or second adapter part 214 to the first adapter part 212 surrounding the vial 20. This has the advantage that when the adapter parts 212, 214 are assembled, they surround a closed space, in which the pierced closure stopper 42 of the vial 20 is located.
• the first adapter part 212 has a pot geometry with a peripheral wall 216 and a bottom wall 218 to receive the vial 20.
• a ring element 222 is provided, from which web-shaped or tongue-shaped elements extending in the axial direction emerge, which are identified by the reference numerals 228 and 230 by way of example. Referring particularly to Figs.
• the tongue-shaped elements 228, 230 are inclined to the longitudinal axis 232 of the connector 200 and thus the vial 20, whereby the first adapter part 212 and the vial 20 form a solid unit when the vial 20 is properly received by the first adapter part 212; because in this case the tongue-shaped elements 228, 230 are based on the vial 20 positioned in the first adapter part 212 on the connecting wall 38 extending between the bottleneck 34 of the vial 20 and its cylindrical body 36.
• the vial 20 from the first adapter part 212 can not be pulled out.
• the ring member 222 which is connected to the front edge of the cup-shaped first adapter part 212 as glued or welded, go further inwardly projecting further tongue-shaped elements 223, 231, as shown by way of example of FIG. 25 on the peripheral surface, ie the cylindrical body 36 of the vial 20 abut.
• the first adapter part 212 has circumferentially limited by surveys locking recesses, as the sectional view of FIG. 20 illustrates. By way of example, two latching depressions are identified by the reference symbols 310, 312.
• the projections delimiting the latching recesses 310, 312 have a tooth-shaped geometry in such a way that their flanks in relation to the second adapter part 214, ie the upper limits in the drawings, run in such a way that a problem-free sliding of the second adapter part 214 on the
• the first adapter part 212 or the insertion of the first adapter part 212 into the second adapter part 214 is made possible because on the corresponding flanks projections 322, 324 of tongue-shaped and in the axial direction of the second adapter part 214 extending elements 314, 316, 318, 320 along slide ,
• the opposite flanks have a correspondingly inclined course, so that when the protruding from the tongue-shaped element 314, 316 projections 322, 324 engage in a detent recess 310, 312, a pulling apart of the adapter parts 312, 314 is no longer possible with normal force application.
• the axially extending tongue-like elements 314, 316, 318, 320 with the inwardly directed projections 322, 324 emanate from a ring element 326, which is fixed in the opening region of the second adapter part 214 as welded.
• the second adapter part 214 has a bell-shaped geometry, as illustrated by the sectional representation, in particular according to FIG. 20. Accordingly, the annular member 326 has a bead-like edge 328 which is connected to the bell-like extension 330 of the second adapter part 214 as welded.
• the tongue-like elements 314, 316, 318, 320 are inclined in the direction of the interior of the second adapter part 214 and resiliently designed so that a trouble telescoping of the first and second adapter part 212, 214 is possible, but - as explained above - a pulling apart is prevented ,
• the lock is designed so that it can only be solved with an additional tool or with at least 300 N trigger force, for example.
• the inner wall of the cylindrical portion of the second adapter part 214 is lined with a seal 332, which in the case of assembled adapter parts 212, 214 seals against the jacket wall 216 of the first adapter part 212. This results in a closed room. If the bottom wall 218 of the first adapter part 212 is likewise closed, the vial 20 is completely closed off from the environment. This is the preferred embodiment.
• seal 332 can have circumferentially circumferential annular elevations 333.
• the free outer edge of the second adapter part 214 rests against the stop when the adapter parts 212, 214 have been properly joined together and thus the cannula 50 has penetrated into the vial 20 to the required extent.
• FIGS. 23 a) to 28 b the connection of the cannula 50 with the interior of the vial 20 is explained in a self-explanatory manner.
• FIGS. 23 a), b) the attachment of the first adapter part 212 surrounding the vial 20 to the second adapter part 214 is illustrated.
• Figs. 24a), b) show the connection again.
• Fig. 25a), b) is reproduced a position in which the projecting from the tongue-like elements 314, 316, 318, 320 in their end region projections 322, 324 already savings in a Rastaus or -Vertiefung 310 engage, so that there is a locking position, but the plug 42 is not completely pierced.
• FIGS. 26 a), b) reflect a position in which the first adapter part 212 has been pushed further into the second adapter part 214. Another deeper intervention is shown in FIG. 27a), b).
• FIG. 28 a), b) the end position is shown, in which the free edge of the second adapter part 214 rests against the annular projection 217 of the first adapter part 212 serving as a stop.
• the edge region of the inner hollow cylindrical portion 268 of the second adapter part 214 and inwardly behind preferably at least partially circumferential projection 270 engages behind the bead-like extension 40 of the vial 20.
• a stop is not a mandatory feature. Rather, an optical display such as a color marking can also serve to make it recognizable to the user that the adapter parts 212, 214 are pushed into one another to such an extent that the stopper 42 is pierced by the cannula 50 to the required extent.
• the break-away connector 52 extending from the bottom wall 245 of the second adapter part 214 can then be removed.
• a connection between the adapter parts 212, 214 is also possible in that the latching recesses 310, 312 are sections of a thread into which the projections 322, 324 engage, so that the first adapter part 212 is joined to the second adapter part 214 in the manner of a screw connection.
• An insolubility is also given, as in the final state, at least one of the inner cylindrical portion 268 after inside protruding projection 270 engages behind the bead-like edge 40 of the vial 20.
• a plurality of projections or a circumferential projection may be provided.
• FIGS. 20 a, 20 b show an embodiment of the transfer device 200 of FIGS. 18 to 28. Since the structure is basically the same, the same reference numerals are used for the same elements.
• the embodiment of the transfer device to be taken from FIGS. 20 a and 20 b differs from that of FIGS. 18 to 28 in that there is no inwardly directed projection of the inner hollow cylindrical section 268 which engages behind the bead-like edge 40 of the vial 20. Otherwise, the same construction is found again.
• the peripheral wall or casing wall 216 of the first adapter part 212 with the ring element 222 runs in the annular gap 269 running between the inner hollow-cylindrical section 268 and the circumferential wall 244 in the case of assembled adapter parts 212, 214.
• the annular gap 269 thus provides a guide when the adapter parts 212, 214 are pushed together.
• FIGS. 29 to 39 An alternative embodiment of a transfer device to be designated as a connector to FIGS. 18 to 28 can be seen in FIGS. 29 to 39.
• the same reference numerals are used for the same elements in principle.
• an insoluble bond between a first adapter part 412 surrounding the vial 20 with the sealing plug 42 and a second adapter part 414 of hood or cup-shaped geometry is given as soon as the first and second adapter parts 412, 414 are connected to one another by latching , Furthermore, the first and second adapter parts 412, 414 surround a closed space surrounding the vial 20, the space already being closed before the cannula 50 emanating from the second adapter part 414 penetrates into the sealing plug 42.
• Undetachable basically means that it is not possible to loosen it without tools or to exert a pull-off force of less than 300 N.
• the first adapter part 412 has a pot geometry with a peripheral wall 216 and a bottom wall 218 to receive the vial 20.
• a peripheral wall 216 which is also referred to as the jacket wall
• latching recesses limited by elevations, two of which are identified by the reference numerals 310 and 312 by way of example.
• the projections which delimit the latching recesses 310, 312 have a tooth-shaped geometry in such a way that their flanks, which run in relation to the second adapter part 414 on the insertion side, ie. H. which run in the drawings in each case upper limits, ramped.
• first and second adapter part 412, 414 a release d. H. Pulling against the direction of penetration of the cannula 50 is no longer possible, acting with the locking recesses 310, 312 radially inwardly projecting projections 423, 425 extending in the axial direction of the second adapter part 414 tongue-shaped elements, some of which by way of example by the reference numeral 416, 418 , 420, 424 are marked.
• the tongue-shaped elements 416, 418, 420, 424 which form locking hooks with their radially inwardly projecting projections 423, 425 are based on a ring element 430 which is materially connected to the second or outer adapter part 414, in particular by welding or gluing. Other types of attachment are also possible.
• the ring element 430 is fixed in the inner region, preferably a bell-like extension 432 of the second adapter part 414, as illustrated in particular in FIG. 31.
• the tongue-shaped elements 416, 418, 420, 424 extending from the ring element 430 in the direction of the bottom wall 434 extending transversely to the longitudinal axis of the adapter part 414 stretch a peripheral edge, that is to say an envelope on, which is adapted to the outer periphery of the first adapter part 412, so that when inserting the first adapter part 412 with the vial 20 in the second or outer adapter part 414 tilting does not take place, but a secure axial guidance is ensured.
• a seal 436 extends from the second adapter part 414 on the inside, consisting of an inner section 438 extending in the longitudinal direction of the adapter section 414 and an outer section parallel thereto and forming a gap therebetween 446 exists.
• the seal 436 has, in section, the geometry of a non-isosceles U whose shorter leg extends on the outside. In the gap extends an edge portion 440 of a coaxial to the circumference swandung 442 of the second adapter part 414 extending inner hollow cylindrical portion 444, as also clearly seen in FIG. 32.
• the seal 436 is bonded to the hollow cylindrical portion 444 or connected in some other suitable manner or otherwise secured as clamped. In this case, outside of the outer portion 446 of the seal 436 is aligned with the outer surface of the hollow cylindrical portion 444, as also seen in FIG. 32 can be seen.
• the outer portion 446 of the seal 436 slides along the inner side of the circumferential wall 216 of the first adapter part 412 and thus seals the outer adapter part 414 with respect to the first or inner adapter part 412.
• the inner surface of the inner portion 438 of the seal 436 has longitudinal ribs 439 which serve to guide the vial 20. Furthermore, the inner portion 438 is chamfered on the inside from its edge (line 441), as shown in FIG. 32 illustrates. This also results in a guide of the vial 20. At the same time there is a sealing against the vial 20, as Fig. 32 illustrates. Furthermore, projections 447 are present on the outside on the outer portion 446 of the seal 436, whereby a seal between the first adapter part 412 and the second adapter part 414 in the region of the locking recesses 310, 312 takes place. This is a seal between the first and second adapter part 412, 414 guaranteed. The seal is also mentioned on the vial 20 and its obliquely extending neck portion (connecting wall 38).
• the latching projections 423, 425 of the tongue-shaped latching elements 416, 418, 420, 424 Due to the interaction of the latching projections 423, 425 of the tongue-shaped latching elements 416, 418, 420, 424 with the latching recesses 310, 312, it is ensured on account of their geometry that, after the latching projections 423, 425 engage in one of the recesses 310, 312, the adapter parts 412 are pulled apart , 414 is no longer possible, but before penetration of the plug 42 only a telescoping in the penetration direction is allowed. This creates a closed space prior to puncturing the plug so that no aerosols arising through the opening of the vial escape to the outside.
• the penetration takes place by further pushing together to an extent that the cannula 50 passes through the stopper 42 and thereby the cannula 50 pierces the stopper 42 completely.
• telescoping of the adapter parts 412, 414 is possible until the lower edge of the second adapter part 414 or the ring element 430 extending in this area comes into contact with a radially encircling web 217, which protrudes from the circumferential wall 216 of the first adapter part 412, as is also the case in connection with the embodiment of FIGS. 18 to 28.
• FIG. 33 the placement of the upper or second adapter part 414 on the lower or inner or first adapter part 412 is shown after the vial 20 has been inserted into the lower adapter part 412.
• the further figures result in the further telescoping of the adapter parts 412, 414, wherein in FIG. 38 the first adapter part 412 is slid in a circumference into the outer adapter part 414, that the latter bears against the revolving stop 217, thus not further telescoping more is possible.
• the cannula 50 has penetrated the closure plug 42 to the required extent.
• the connector 52 can be terminated to z. B. initiate the mixing process via a hose of a solvent bag.
• a stop 217 is not mandatory.
• a user can also be illustrated by an optical marking, such as a circumferential ring, that the adapter parts 412, 414 are pushed into each other to the required extent that the cannula 50 has pierced the plug 42 to a sufficient extent.
• an optical marking such as a circumferential ring
• Bottle neck 134 second outer hollow cylindrical
• cylindrical body 136 third outer hollow cylindrical
• Plugs / plugs 147 Projection / Clamp rib, hollow cylinder section 150 Transverse wall
• Adapter part 412 adapter part
• Adapter part 414 adapter part
• Element / fixing element 424 tongue-shaped element
• Projection 439 longitudinal ribs

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